Transcutaneous neurostimulator for treating hypertension

ABSTRACT

A neurostimulation device includes an external neurostimulator worn by a patient using a bracing element that braces a portion of the patient&#39;s body. The external neurostimulator delivers neurostimulation to modulate a cardiovascular function of the patient. In one embodiment, the external stimulator delivers the neurostimulation transcutaneously to a stimulation target in the patient&#39;s body using surface stimulation electrodes placed on the body approximately over the stimulation target.

CLAIM OF PRIORITY

This application is a continuation of and claims the benefit of priorityunder 35 U.S.C. §120 to U.S. patent application Ser. No. 12/869,593,filed on Aug. 26, 2006, which is a continuation of and claims thebenefit of priority under 35 U.S.C. §120 to U.S. patent application Ser.No. 11/548,359, filed on Oct. 11, 2006, now issued as U.S. Pat. No.7,797,041, which are hereby incorporated by reference herein in theirentirety.

CROSS-REFERENCE TO RELATED APPLICATION

This application is related to co-pending, commonly assigned, U.S.patent application Ser. No. 11/548,348, entitled “PERCUTANEOUSNEUROSTIMULATOR FOR MODULATING CARDIOVASCULAR FUNCTION,” filed Oct. 11,2006, now issued as U.S. Pat. No. 7,797,046, which is herebyincorporated by reference its entirety.

TECHNICAL FIELD

This document relates generally to neurostimulation and particularly toa neurostimulation system for modulating cardiovascular function usingan external neurostimulator and surface and/or percutaneous electrodes.

BACKGROUND

Neurostimulation has been applied or proposed to modulate variousphysiologic functions and treat various diseases. One example is themodulation of cardiovascular functions by stimulating sympathetic andparasympathetic nerves that innervate the heart. Activities in the vagusnerve, including artificially applied electrical stimuli, modulate theheart rate and contractility (strength of the myocardial contractions).Electrical stimulation applied to the vagus nerve is known to decreasethe heart rate and the contractility, lengthening the diastolic phase ofa cardiac cycle. This ability of the vagal nerve stimulation may beutilized, for example, to control myocardial remodeling. Electricalstimulation applied at acupuncture points is also known to havetherapeutic effects in cardiovascular functions.

Neurostimulation is known to provide therapeutic benefit when appliedshortly after the occurrence of a cardiac disorder event such as acuteMI. For example, after the acute MI, adverse ventricular remodelingstarts and the heart is more susceptible to arrhythmias.Neurostimulation may be applied to control the post-MI ventricularremodeling and prevent the arrhythmias from occurring. Thus, there is aneed for a neurostimulation system that can be deployed promptlyfollowing a cardiac disorder event such as acute MI. Because the post-MIneurostimulation may not be needed on a long-term and/or continuousbasis, there is also a need for the neurostimulation system to besuitable for temporary and/or intermittent use.

SUMMARY

A neurostimulation device includes an external neurostimulator worn by apatient using a bracing element that braces a portion of the patient'sbody. The external neurostimulator delivers neurostimulation to modulatea cardiovascular function of the patient.

In one embodiment, a system for transcutaneous neurostimulation tomodulate a cardiovascular function in a body includes a transcutaneousneurostimulation device configured to be worn on the body. Thetranscutaneous neurostimulation device includes surface stimulationelectrodes configured to be placed on surface of the body, an externalneurostimulator, and a bracing element. The external neurostimulatordelivers neurostimulation transcutaneously to a stimulation target inthe body through the surface stimulation electrodes. The bracing elementbraces a portion of the body to hold the external neurostimulator on asurface location of the body.

In one embodiment, a method is provided for modulating a cardiovascularfunction in a body by transcutaneous neurostimulation. An externalneurostimulator is held on the body using a bracing element configuredto brace a portion of the body. Surface stimulation electrodes areplaced on the body, with at least one of the surface stimulationelectrodes placed approximately over a stimulation target in the body.Neurostimulation is transcutaneously delivered to the stimulation targetfrom the external neurostimulator through the surface stimulationelectrodes. The delivery of the neurostimulation is controlled byexecuting a stimulation algorithm adapted to modulate the cardiovascularfunction.

This summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects of the invention will be apparent to persons skilled in the artupon reading and understanding the following detailed description andviewing the drawings that form a part thereof. The scope of the presentinvention is defined by the appended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate generally, by way of example, variousembodiments discussed in the present document. The drawings are forillustrative purposes only and may not be to scale.

FIG. 1 is an illustration of an embodiment of a neurostimulation systemand portions of an environment in which the neurostimulation system isused.

FIG. 2 is a block diagram illustrating an embodiment of portions of acircuit of the neurostimulation system.

FIG. 3 is a block diagram illustrating another embodiment of portions ofthe circuit the neurostimulation system.

FIG. 4 is an illustration of an embodiment of an externalneurostimulator of the neurostimulation system.

FIG. 5 is an illustration of an embodiment of surface stimulationelectrodes coupled to the external neurostimulator.

FIG. 6 is an illustration of another embodiment of surface stimulationelectrodes coupled to the external neurostimulator.

FIG. 7 is an illustration of an embodiment of percutaneous stimulationelectrodes coupled to the external neurostimulator.

FIG. 8 is an illustration of another embodiment of percutaneousstimulation electrodes coupled to the external neurostimulator.

FIG. 9 is an illustration of another embodiment of percutaneousstimulation electrodes coupled to the external neurostimulator.

FIG. 10 is an illustration of an embodiment of a percutaneousstimulation electrode coupled to the external neurostimulator through askin-mounted connector.

FIG. 11 is an illustration of an embodiment of a percutaneousstimulation electrode coupled to the external neurostimulator through alead with a magnet.

FIG. 12 is an illustration of an embodiment of the externalneurostimulator coupled to a bracing element.

FIG. 13 is an illustration of another embodiment of the externalneurostimulator coupled to a bracing element.

FIG. 14 is an illustration of an embodiment of a neurostimulation systemincluding a neurostimulation device, an implantable medical device, andan external system.

FIG. 15 is a block diagram illustrating an embodiment of portions of acircuit of the neurostimulation system of FIG. 14.

FIG. 16 is an illustration of an embodiment of a neurostimulation systemincluding a neurostimulation device and a user communication device.

FIG. 17 is a block diagram illustrating an embodiment of portions of acircuit of the neurostimulation system of FIG. 16.

FIG. 18 is an illustration of another embodiment of surface stimulationelectrodes coupled to the external neurostimulator.

FIG. 19 is an illustration of an embodiment of surface and percutaneousstimulation electrodes coupled to the external neurostimulator.

FIG. 20 is an illustration of another embodiment of surface andpercutaneous stimulation electrodes coupled to the externalneurostimulator.

FIG. 21 is an illustration of another embodiment of surface andpercutaneous stimulation electrodes coupled to the externalneurostimulator.

FIG. 22 is a flow chart illustrating a method for modulating acardiovascular function using transcutaneous or percutaneousneurostimulation.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. References to “an”, “one”, or “various” embodimentsin this disclosure are not necessarily to the same embodiment, and suchreferences contemplate more than one embodiment. The following detaileddescription provides examples, and the scope of the present invention isdefined by the appended claims and their legal equivalents.

This document discusses a neurostimulation system including an externalneurostimulator that modulate cardiovascular functions by deliveringneurostimulation through transcutaneous and/or percutaneous electrodes.Implantable neurostimulation systems provide post-MI neurostimulationthat has anti-remodeling and anti-arrhythmic effects. Recent datasuggest maximum benefit to a patient suffering an acute MI is achievedwhen the neurostimulation is delivered within a week following the acuteMI. The implantation of a neurostimulation system may require asubstantially invasive operation that can be performed only by speciallytrained medical personnel. A long-term and/or continuous delivery of theneurostimulation may not be necessary or beneficial. For these and otherreasons, a treatment using an implantable neurostimulation system mayneither be made available when most needed nor be cost effective. Toprovide neurostimulation when an implantable neurostimulation system isunavailable, cost ineffective, or otherwise unsuitable, the presentneurostimulation system uses an external neurostimulator coupled totranscutaneous and/or percutaneous electrodes. Such a system providesfor a potentially fast therapy response to a cardiovascular disorderevent such as acute MI and a potentially cost-effective means fordelivering neurostimulation on a temporarily and/or intermittent basis.

FIG. 1 is an illustration of an embodiment of a neurostimulation system100 and portions of an environment in which system 100 is used. System100 includes a neurostimulation device 104 configured to be worn on abody 102 of a patient. Neurostimulation device 104 includes an externalneurostimulator 110 that delivers neurostimulation for modulating thepatient's cardiovascular functions, a bracing element 112 to holdexternal neurostimulator 110 onto body 102 at a specified surfacelocation, and electrodes through which the neurostimulation is deliveredfrom external neurostimulator 110 to body 102. In one embodiment,neurostimulation device 104 is used as part of an emergency response toa cardiac disorder event occurring in the patient's heart 101, such asan acute MI. In another embodiment, neurostimulation device 104 is usedfor temporary or intermittent delivery of neurostimulation, such as whenthe implantation of a neurostimulation system is not justified.

In the illustrated embodiment, neurostimulation device 104 is donnedover the knee area for stimulating the peroneal nerve at an acupuncturepoint known as GB-34 on the Gall Bladder Meridian of the foot. Theacupuncture point GB-34 is also referred to as Yang Ling Quan (YangMound Spring) and about one inch below the knee, in the depression onthe outer face of the shin, and corresponding to the point where thecommon peroneal nerve bifurcates into the superficial and deep peronealnerves. Electrical stimulation at the acupuncture point GB-34 is knownto have cardiovascular therapeutic effects such as beinganti-remodeling, anti-hypertensive, and anti-arrhythmia. Potentialresults of electrical stimulation applied to the GB-34 include reducedheart rate, reduced blood pressure, and reduced arrhythmiavulnerability. In various embodiments, neurostimulation device 104 isused to treat a patient with cardiovascular diseases such as ischemicheart disease, heart failure, and hypertension.

Other acupuncture points known to have cardiovascular effects inresponse to electrical stimulation include PC-2 to PC-9 (on thePericardium Meridian, running along the arm from below the armpit fold,along the transverse crease of the wrist, to the tip of the middlefinger), HT-7 (on the Heart Meridian, on the transverse crease on thepalm side of the wrist), BL-14 (on the Bladder Meridian, about 1.5inches lateral to the lower border of the spinous process of the fourththoracic vertebra), BL-16 (on the Bladder Meridian, about 1.5 incheslateral to the lower border of the spinous process of the sixth thoracicvertebra), and GV-11 (on the Governing Vessel Meridian, below thespinous process of the fifth thoracic vertebra).

In one embodiment, the neurostimulation device 104 is used to stimulateone or more nerves of the autonomic nervous system, such as to moduleheart rate and blood pressure. Stimulation of the vagus nerve followingan acute MI is known to significantly reduce ventricular dilationfollowing coronary artery ligation, manifested as decreased systolic anddiastolic volumes.

In various embodiments, bracing element 112 includes a sleeve, a strap,or a belt configured to brace a portion of body 102, such as the knee,wrist, arm, leg, thigh, torso, neck, and head. Brace element 112 isadjustable in size and/or available in a plurality of sizes toaccommodate patients with substantially different sizes.

In one embodiment, neurostimulation device 104 is a transcutaneousneurostimulation device. External neurostimulator 110 delivers theneurostimulation to a stimulation target in body 102 using surfacestimulation electrodes placed on stimulation sites on the surface ofbody 102 approximately over the stimulation target. In one embodiment,such a transcutaneous neurostimulation device is made for donning by thepatient or another person by following simple instructions. Examples ofthe surface stimulation electrodes used to deliver transcutaneousneurostimulation are discussed below with reference to FIGS. 5-6.

In another embodiment, neurostimulation device 104 is a percutaneousneurostimulation device. External neurostimulator 110 delivers theneurostimulation to a stimulation target in body 102 using at least onepercutaneous stimulation electrode that is inserted into body 102 tolodge on or about a stimulation target in body 102. In one embodiment,such a percutaneous neurostimulation device is made available for use byemergency response medical personnel to provide neurostimulationimmediately following an acute MI. In another embodiment, thepercutaneous neurostimulation device is provided for temporary use whilethe patient is evaluated or waiting for a more permanent therapy such asan implantable device therapy. In another embodiment, the percutaneousneurostimulation device is used when the stimulation target is difficultto reach by the transcutaneous neurostimulation, thereby expanding therange of potential stimulation targets. Examples of the percutaneousstimulation electrodes used to deliver percutaneous neurostimulation arediscussed below with reference to FIGS. 7-11.

FIG. 2 is a block diagram illustrating an embodiment of portions of acircuit of system 100, including stimulation electrodes 214 and anexternal stimulator 210. In one embodiment, stimulation electrodes 214include surface stimulation electrodes. In another embodiment,stimulation electrodes 214 include percutaneous stimulation electrodes.In another embodiment, stimulation electrodes 214 include transcutaneousand percutaneous stimulation electrodes.

External neurostimulator 210 is a specific embodiment of externalneurostimulator 110 and includes a stimulation output circuit 216, astimulation controller 218, and a memory circuit 220. Stimulation outputcircuit 216 is electrically coupled to stimulation electrodes 214 anddelivers the neurostimulation to a stimulation target in body 102through stimulation electrodes 214. Stimulation controller 218 controlsthe delivery of the neurostimulation by executing a stimulationalgorithm for modulating a cardiovascular function. Memory circuit 220stores the stimulation algorithm including stimulation parameters.

FIG. 3 is a block diagram illustrating another embodiment of portions ofthe circuit of system 100, including stimulation electrodes 214, anexternal neurostimulator 310, and an external sensor 322. Externalneurostimulator 310 is a specific embodiment of external neurostimulator210 and includes stimulation output circuit 216, a stimulationcontroller 318, a stimulator telemetry circuit 324, a battery 326, and auser interface 328.

Stimulation output circuit 216 delivers neurostimulation throughstimulation electrodes 214. In one embodiment, the neurostimulation isin the form of electrical pulses. In other embodiments, theneurostimulation includes any form of energy that is capable ofeliciting action potentials in a target nerve, such as magnet field,light, and ultrasound.

Stimulation controller 318 is a specific embodiment of stimulationcontroller 218 and controls the delivery of the neurostimulation byexecuting a stimulation algorithm for modulating a cardiovascularfunction. The stimulation algorithm includes stimulation parametersselected to modulate the cardiovascular function. Examples of thestimulation parameters for controlling the delivery of electricalneurostimulation pulses include pulse amplitude, pulse width,stimulation frequency (or inter-pulse interval), periodic dose, and dutycycle. The pulse amplitude and pulse width are selected to ensure thateach pulse elicits an action potential in the target nerve. In oneembodiment, the stimulation frequency is between approximately 0.1 and200 Hz, with between approximately 1 and 30 Hz as a specific example formodulating cardiovascular functions. In one embodiment, in which theelectrical neurostimulation pulses are delivered transcutaneously usingsurface electrodes, the stimulation frequency is between approximately 1and 5 Hz. In one embodiment, in which the electrical neurostimulationpulses are delivered percutaneously using at least one percutaneouselectrode, the stimulation frequency is between approximately 1 and 50Hz. The periodic dose is a time interval during which a patient istreated with neurostimulation for each predetermined period. In oneembodiment, the predetermined period is a day, and the periodic dose isa daily dose. The duty cycle is the duty cycle of the neurostimulationduring the time interval during of the period dose. For example, if thepatient is to receive a neurostimulation therapy for two hours each day,the periodic dose is 2 hours/day (or the daily dose is 2 hours). If theneurostimulation during those two hours is delivered intermittently withalternating on- and off-periods, the duty cycle is the ratio of theon-period to the sum of the on-period and the off-period. In oneembodiment, the daily dose is between approximately 0.5 and 24 hours. Inone embodiment, the duty cycle is between approximately 10 and 50%. Theon-period is between approximately 10 and 120 seconds, and theoff-period is between approximately 50 and 120 seconds.

In the illustrated embodiment, stimulation controller 318 includes afeedback controller 330, a command receiver 332, a clock 334, and analarm signal generator 336. In various embodiments, stimulationcontroller 318 includes one or more of feedback controller 330, commandreceiver 332, clock 334, and alarm signal generator 336. Feedbackcontroller 330 controls the delivery of the neurostimulation using afeedback control signal that indicates a need to start, stop, or adjustthe neurostimulation. In one embodiment, the feedback control signalprovides for automatic verification of neural response to theneurostimulation. In one embodiment, external sensor 322 senses thefeedback control signal. In a specific embodiment, external sensor 332is a sensor included in external neurostimulator 310. In anotherspecific embodiment, external sensor 332 is electrically connected toexternal neurostimulator 310. In another specific embodiment, externalsensor 332 is communicatively coupled to external neurostimulator 310via telemetry. Examples of external sensor 322 include a heart ratesensor to sense a heart rate, a pressure sensor to measure a bloodpressure, and a plethysmographic sensor to sense plethysmogram signal.In another embodiment, feedback controller 330 receives the feedbackcontrol signal from stimulator telemetry circuit 324. Another device,such as an implantable device in body 102 or an external device, sensesthe feedback control signal and telemeters the feedback control signalto external neurostimulator 310.

Command receiver 332 receives a stimulation command for starting,pausing, or stopping the delivery of the neurostimulation. In oneembodiment, the stimulation command is received from another device. Inanother embodiment, the stimulation command is received from userinterface 328. Clock 334 keeps track of the time. In one embodiment,clock 334 times the delivery of a neurostimulation therapy according toa programmed schedule. For example, when the patient is to receive aperiodic dose according to the programmed schedule, clock 334 produces astimulation command and transmits the stimulation command to commandreceiver 332 to starting the delivery of the neurostimulation. Alarmsignal generator 336 generates an alarm signal to remind the patient oranother person that the patient is due for receiving the periodic doseof the neurostimulation. In one embodiment, alarm signal generator 336generates an alarm signal indicating a problem or potential problem withexternal neurostimulator 310, such as a low battery level. In anotherembodiment, alarm signal generator 336 an audio tone as an auditoryfeedback signal confirming that the neurostimulation delivered fromexternal neurostimulator 310 is producing desirable result, such asindicated by the feedback control signal.

Memory circuit 220 stores the stimulation algorithm including thestimulation parameters. In one embodiment, memory circuit 220 alsostores the history of delivery of the neurostimulation. In one example,the patient is given a transcutaneous neurostimulation device andinstructed to apply the neurostimulation according to a treatmentschedule. If the patient is due to receive the treatment, but thetranscutaneous neurostimulation device is not worn or turned on, alarmsignal generator 336 generates an alarm signal as a reminder to thepatient.

User interface 328 includes a presentation device 338 and a user inputdevice 340. Presentation device 338 includes a display 342 and an audiotone generator 344. In one embodiment, display 342 a liquid crystaldisplay (LCD) screen. Display 342 displays information including, butnot limited to, power on/off status of the external neurostimulator,parameters produced using signal sensed by external sensor 322 (such asthe heart rate and the blood pressure), the time, and the batterystatus. User input device 340 includes a power switch 346 and astimulation intensity adjuster 348. Power switch 328 allows the patientor another person to turn external neurostimulator 310 on and off.Stimulation intensity adjuster 348 allows the patient or another personto adjust the stimulation parameters to change the intensity of theneurostimulation. In one embodiment, display 342 indicates whether theneurostimulation elicits an expected response, and the patient can usestimulation intensity adjuster 348 to change the intensity of theneurostimulation if the current intensity causes discomfort. In anotherembodiment, feedback controller 330 adjusts the intensity of theneurostimulation automatically using the feedback control signal suchthat stimulation intensity adjuster 348 is unnecessary.

Battery 326 supplies the power for the operation of the circuit ofexternal neurostimulator 310. In one embodiment, battery 326 is arechargeable battery. In one embodiment, the patient using system 100 isprovided with a battery charger that uses standard AC power. Whenneeded, the battery charger is equipped with one or more adaptors foruse in different countries.

FIG. 4 is an illustration of an embodiment of an externalneurostimulator 410, which is a specific embodiment of externalneurostimulator 110. FIG. 4 shows a front view of externalneurostimulator 410, which includes a chassis 454 to house a circuitsuch as the circuit of external neurostimulator 210 or 310. A userinterface including a display 442 and user input device 440 areincorporated onto chassis 454. Display 442 represents an embodiment ofdisplay 342. User input device 440 represents an embodiment of userinput device 340 and includes buttons, knobs, and/or other switches thatare operated by the patient or another person.

FIG. 5 is an illustration of an embodiment of surface stimulationelectrodes coupled to external neurostimulator 410. FIG. 5 shows a rearview of external neurostimulator 410. Surface stimulation electrodes556A-B are incorporated onto the side of chassis 454 that is in contactof the surface of body 102 when being used. External neurostimulator 410is placed on a surface location of body 102 such that surfacestimulation electrodes 556A-B are positioned approximately over astimulation target in body 102. In one embodiment, surface stimulationelectrodes 556A-B each have a surface area between approximately 5 and100 mm².

In the illustrated embodiment, surface stimulation electrodes 556A-B areshown as disc electrodes for illustrate purposes only. Other examples ofthe configuration of surface stimulation electrodes 556A-B include stripelectrodes, ring electrodes, and concentric electrodes.

FIG. 6 is an illustration of another embodiment of surface stimulationelectrodes coupled to external neurostimulator 410. Surface stimulationelectrodes 656A-B are each connected to external neurostimulator 410using a lead. In the illustrated embodiment, surface stimulationelectrodes 656A is connected to external neurostimulator 410 using alead 658A, and is incorporated onto a skin patch 659A. Surfacestimulation electrodes 656B is connected to external neurostimulator 410using a lead 658B, and is incorporated onto a skin patch 659B. Skinpatches 659A-B are attached to the surface of body 102 using adhesive.In another embodiment, surface stimulation electrodes 656A-B areincorporated onto a single skin patch and connected to externalneurostimulator 410 using a multi-conductor lead.

FIG. 7 is an illustration of an embodiment of percutaneous stimulationelectrodes coupled to external neurostimulator 410. Percutaneousstimulation electrodes 756A-B are each configured to pierce the skin ofbody 102 and lodge in a specified stimulation site in body 102. Thespecific stimulation site is on or about a target nerve.

Percutaneous stimulation electrodes 756A-B are each a wire electrodeincluding a wire having a proximal end coupled to externalneurostimulator 410 and a distal end configured to lodge in thespecified stimulation site in body 102. In one embodiment, the wireincludes a coiled portion such that when each of electrodes 756A-B exitsbody 102, the wire is coiled as it exits the skin. The coiled portion isemployed to reduce the likelihood of infection with percutaneous wiresbecause greater mechanical stability and encapsulation are achieved withthe coiled wire. In the illustrated embodiment, the wire electrode is aneedle electrode, where the wire is substantially rigid. The distal endis a sharp tip suitable for penetrating tissue and includes barbs (760Aor 760B) to provide a stable electrode placement. In the illustratedembodiment, percutaneous stimulation electrodes 756A-B are mounted onand projecting from external neurostimulator 410. In another embodiment,percutaneous stimulation electrodes 756A-B are each connected toexternal neurostimulator 410 using a lead.

FIG. 8 is an illustration of an embodiment of percutaneous stimulationelectrodes coupled to external neurostimulator 410. Percutaneousstimulation electrodes 856A-B are each a wire electrode including a wirehaving a proximal end coupled to external neurostimulator 410 and adistal end configured to lodge in the specified stimulation site in body102. In one embodiment, the wire includes a coiled portion such thatwhen each of electrodes 856A-B exits body 102, the wire is coiled as itexits the skin. In the illustrated embodiment, the wire electrode is aflexible electrode, where the wire is substantially flexible.Percutaneous stimulation electrodes 856A-B each includes a distal endthat is a J-shaped hook (860A or 860B). In one embodiment, percutaneousstimulation electrodes 856A-B are each introduced into tissue with ahollow needle.

FIG. 9 is an illustration of an embodiment of percutaneous stimulationelectrodes coupled to external neurostimulator 410. An implantablecapsule 962 includes percutaneous stimulation electrodes 956A-B each onone of its opposite ends. To deliver the neurostimulation, capsule 962is subcutaneously implanted, and a multi-conductor lead 958 providespercutaneous connections between each of percutaneous stimulationelectrodes 956A-B and external neurostimulator 410. In one embodiment,capsule 962 has a cylindrical elongate body coupled between oppositeends. The length of capsule between the opposite ends is betweenapproximately 5 mm and 25 mm. The cylindrical elongate body has adiameter between approximately 1 mm and 10 mm. In one embodiment,capsule 962 is implanted by injection through a hollow injection devicehaving an end configured to reach the stimulation target in body 102.Examples of the hollow injection device include a hollow needle andhollow catheter.

FIG. 10 is an illustration of an embodiment of a percutaneousstimulation electrode 1056 coupled to external neurostimulator 410through a skin-mounted connector 1064. Connector 1064 includes a buttonmounted on a surface location of body 102 and is electrically connectedto percutaneous stimulation electrode 1056. Connector 1066 is to beconnected to connector 1064 and to external neurostimulator 410 througha lead 1058. In one embodiment, connectors 1064 and 1066 arebutton-connectors allowing for a snap-on connection. In anotherembodiment, connectors 1064 and 1066 are flat discs including magnets tohold to each other magnetically. In another embodiment, connectors 1064and 1066 are a pair of slot and groove slide-in connectors with latchand push-button release. The use of connectors 1064 and 1066 allowsexternal neurostimulator 410 to be disconnected from percutaneousstimulation electrode 1056, for example, when the patient is not treatedwith the neurostimulation. The use of these connectors also providemechanical strain relief. In various embodiments, percutaneousstimulation electrode 1056 includes any electrode suitable forimplantation in body 102 to deliver the neurostimulation, with electrode756A/B being a specific example.

FIG. 11 is an illustration of an embodiment of a percutaneousstimulation electrode coupled to external neurostimulator 410 through alead 1158 with a magnet 1168. Capsule 962, which includes percutaneousstimulation electrodes 956A-B, is to be electrically connected toexternal neurostimulator 410 through lead 1158. Magnet 1168 is coupledto lead 1158 and is to be placed onto a surface location of body 102over implanted capsule 962 to prevent capsule 962 from drifting in thetissue.

FIGS. 5-11 illustrate various stimulation electrode configurations asspecific examples of surface and percutaneous stimulation electrodes. Atranscutaneous neurostimulation device includes at least a pair ofsurface stimulation electrode. A percutaneous neurostimulation deviceincludes at least one percutaneous stimulation electrode. In oneembodiment, the neurostimulation is delivered using a pair ofpercutaneous stimulation electrodes. In another embodiment, theneurostimulation is delivered using a percutaneous stimulation electrodeplaced on or about the stimulation target and a surface stimulationelectrode serving as a return electrode. Some additional examples ofelectrode configurations are discussed below with reference to FIGS.18-21. In various embodiments, neurostimulation is deliveredtranscutaneously or percutaneously using a pair of stimulationelectrodes selected from any of those illustrated in FIGS. 5-11 as wellas any other suitable surface and percutaneous electrodes.

FIG. 12 is an illustration of an embodiment of external neurostimulator410 coupled to a bracing element. A neurostimulation device 1214includes external neurostimulator 410 affixed to a bracing element 1212.Bracing element 1212 is configured to brace a portion of body 102 tohold external neurostimulator 410 onto the surface of body 102. In oneembodiment, in which neurostimulation device 1214 is a transcutaneousneurostimulation device, bracing element 1212 allows surface stimulationelectrodes on external neurostimulator 410 (such as electrodes 556A-B)to be placed securely on a surface location of body 102 approximatelyover a stimulation target in body 102. In another embodiment, in whichneurostimulation device 1214 is a percutaneous neurostimulation device,bracing element 1212 allows external neurostimulator 410 to be worn on asurface location of body 102 over or near a stimulation target in body102 on or about which at least one percutaneous stimulation electrode islodged. In the illustrated embodiment, bracing element 1212 includes abelt. In one embodiment, belt 1212 is detachably coupled to externalneurostimulator 410. In one embodiment, belt 1212 has an adjustablelength. In one embodiment, belt 1212 includes a wrist band, andneurostimulation device 1214 has a configuration similar to a wristwatch. In other embodiments, belt 1212 has a length suitable for bracinganother portion of body 102, such as the knee, arm, leg, thigh, torso,neck, or head.

FIG. 13 is an illustration of another embodiment of externalneurostimulator 410 coupled to a bracing element. An neurostimulationdevice 1314 includes external neurostimulator 410 affixed to a bracingelement 1312, which has substantially same functions as bracing element1212 except for being a sleeve. The choice between using belt 1212 andsleeve 1312 may depend on factors such as location on body 102 andpatient preference. In one embodiment, sleeve 1312 is detachably coupledto external neurostimulator 410. In one embodiment, sleeve 1312 is madeof an elastic material to provide an adjustable length. In oneembodiment, sleeve 1312 includes a knee sleeve, and neurostimulationdevice 1314 is worn as a knee guard. In other embodiments, sleeve 1312has a length suitable for bracing another portion of body 102, such asthe wrist, arm, leg, thigh, torso, neck, or head.

External neurostimulator 410 is illustrated in FIGS. 4-9, 12, and 13 asa specific example and not as a restriction. In various embodiments, theexternal neurostimulator of the present neurostimulation system may haveany configuration suitable for being incorporated into aneurostimulation device worn by the patient, such as neurostimulationdevice 104, to deliver transcutaneous and/or percutaneousneurostimulation as discussed in this document.

FIG. 14 is an illustration of an embodiment of a neurostimulation system1400. System 1400 includes a neurostimulation device 1404, animplantable medical device 1470, and an external system 1474.Neurostimulation device 1404 is a specific embodiment ofneurostimulation device 104 and includes an external neurostimulator1410 coupled to bracing element 112. In one embodiment, externalneurostimulator 1410 includes the circuit of external neurostimulator310 as discussed above. A telemetry link 1411 provides for communicationbetween external neurostimulator 1410 and implantable medical device1470. A telemetry link 1413 provides for communication betweenimplantable medical device 1470 and external system 1474. A telemetrylink 1475 provides for communication between external neurostimulator1410 and external system 1474.

In one embodiment, implantable medical device 1470 includes animplantable cardiac rhythm management (CRM) device. Implantable medicaldevice 1470 includes, but is not limited to, one or more of a pacemaker,a cardioverter/defibrillator, a cardiac resynchronization therapydevice, a cardiac remodeling control therapy device, a neurostimulationdevice, a drug delivery device, a biologic therapy device, and a patientmonitoring device. A lead system 1472 includes one or more leadsproviding for electrical and/or other connections between heart 101 andimplantable medical device 110.

External system 1474 allows for programming of implantable medicaldevice 1470 and/or external neurostimulator 1410 and receives signalsacquired by implantable medical device 1470 and/or externalneurostimulator 1410. In one embodiment, external system 1474 includes aprogrammer. In another embodiment, external system 1474 is a patientmanagement system including an external device in proximity of body 102(in which implantable medical device 1470 is implanted and on whichneurostimulation device 1404 is worn), a remote device in a relativelydistant location, and a telecommunication network linking the externaldevice and the remote device. The patient management system allows foraccess to implantable medical device 1470 and/or externalneurostimulator 1410 from a remote location, such as for monitoringpatient status, adjusting therapies, and obtaining patient's medicalrecords stored in a remote location.

Telemetry link 1413 is a wireless communication link providing for datatransmission between implantable medical device 1470 and external system1474. Telemetry link 1413 provides for data transmission fromimplantable medical device 1470 to external system 1474. This mayinclude, for example, transmitting real-time physiological data acquiredby implantable medical device 1470, extracting physiological dataacquired by and stored in implantable medical device 1470, extractingtherapy history data stored in implantable medical device 1470, andextracting data indicating an operational status of implantable medicaldevice 1470 (e.g., battery status and lead impedance). Telemetry link1413 also provides for data transmission from external system 1474 toimplantable medical device 1470. This may include, for example,programming implantable medical device 1470 to acquire physiologicaldata, programming implantable medical device 1470 to perform at leastone self-diagnostic test (such as for a device operational status),programming implantable medical device 1470 to enable an availablemonitoring or therapeutic function, and programming implantable medicaldevice 1470 to adjust therapeutic parameters such as pacing and/orcardioversion/defibrillation parameters.

Telemetry link 1475 is a wireless communication link providing for datatransmission between external neurostimulator 1410 and external system1474. Telemetry link 1475 provides for data transmission from externalneurostimulator 1410 to external system 1474. This may include, forexample, transmitting real-time physiological data acquired by externalneurostimulator 1410, extracting physiological data acquired by andstored in external neurostimulator 1410, extracting therapy history datastored in external neurostimulator 1410, and extracting data indicatingan operational status of external neurostimulator 1410 (e.g., batterystatus). Telemetry link 1475 also provides for data transmission fromexternal system 1474 to external neurostimulator 1410. This may include,for example, programming external neurostimulator 1410 to adjust thestimulation parameters, and transmitting a user command to externalneurostimulator 1410 to initiate a delivery of the neurostimulation.

Telemetry link 1411 is a wireless communication link providing for datatransmission between external neurostimulator 1410 and implantablemedical device 1470. Telemetry link 1475 provides for data transmissionfrom implantable medical device 1470 to external neurostimulator 1410.This may include, for example, transmitting a signal sensed byimplantable medical device 1470 to external neurostimulator 1410 for useas the feedback control signal controlling the neurostimulation, andtransmitting a neurostimulation command to external neurostimulator 1410to initiate a delivery of the neurostimulation, such as when apredetermined-type cardiac event is detected by implantable medicaldevice 1470. In one embodiment, telemetry link 1475 also provides fordata transmission from external neurostimulator 1410 to implantablemedical device 1470.

System 1400 allows the neurostimulation to be initiated by any one ofexternal neurostimulator 1410, implantable medical device 1470, andexternal system 1474. In one embodiment, external neurostimulator 1410and/or implantable medical device 1470 initiate a neurostimulationtherapy upon detecting a predetermined signal or condition. Externalsystem 1474 initiates a neurostimulation therapy upon receiving a usercommand.

FIG. 15 is a block diagram illustrating an embodiment of portions of acircuit of system 1400. The circuit includes an implantable medicaldevice 1570 coupled to lead system 1472, an external system 1574, andexternal neurostimulator 310 coupled to stimulation electrodes 214.

Implantable medical device 1570 is a specific embodiment of implantablemedical device 1470 and includes a CRM circuit 1580, a sensor 1576, asensor processing circuit 1578, a command generator 1582, and an implanttelemetry circuit 1584. CRM circuit 1580 delivers one or more CRMtherapies. In one embodiment, CRM circuit 1580 includes one or more of apacemaker and a cardioverter/defibrillator to delivery cardiacelectrical stimulation to heart 101 through lead system 1472. Sensor1576 senses a physiologic signal. Sensor processing circuit 1578produces the feedback control signal used by feedback controller 330 ofexternal neurostimulator 310 using the sensed physiologic signal. In oneembodiment, the physiological signal is a cardiac signal, and thefeedback control signal is indicative of a cardiac condition to bemodulated by the neurostimulation. Command generator 1582 produces theneurostimulation command that initiates a neurostimulation therapy, suchas upon detecting a specified-type cardiac event (such as ischemia orMI) from the cardiac signal. Implant telemetry circuit 1584 transmitsthe feedback control signal and/or the neurostimulation command to theexternal neurostimulator 310.

External system 1574 includes a user interface 1586, a programmingmodule 1588, and an external telemetry circuit 1590. User interface 1586allows a user such as a physician or other caregiver to programimplantable medical device 1570 and/or external neurostimulator 310 andobserve signals acquired by implantable medical device 1470 and/orexternal neurostimulator 310. Programming module 1588 converts userinput received by user interface 1586 to programming codes to betransmitted to implantable medical device 1470 and/or externalneurostimulator 310 by external telemetry circuit 1590. In theillustrated embodiment, user interface 1586 allows the user to enter theuser command for initiating a neurostimulation therapy, and programmingmodule 1588 includes a command generator 1592 to produce theneurostimulation command upon receiving the user command for initiatingthe neurostimulation therapy. External telemetry circuit 1590 transmitsthe neurostimulation command to external neurostimulator 310.

FIG. 16 is an illustration of an embodiment of a neurostimulation system1600. System 1600 includes a neurostimulation device 1604 and a usercommunication device 1605. Neurostimulation device 1604 is a specificembodiment of neurostimulation device 104 and includes an externalneurostimulator 1610 coupled to bracing element 112. User communicationdevice 1605 includes a communicator 1611 and a bracing element 1613. Inone embodiment, external neurostimulator 1610 includes substantially thecircuit of external neurostimulator 310 except user interface 328, whichis included in communicator 1611. A telemetry link 1615 provides forcommunication between external neurostimulator 1610 and communicator1611. System 1600 provides for easy access to and observation of a userinterface when the external stimulator is held onto a bodily locationthat is not convenient to reach and see by at least the patient wearingthe external stimulator, such as the knee or the neck. Usercommunication device 1605 is a portable device that is carried or wornby the patient in a way allowing for convenient access by the patent.When user communication device 1605 is worn by the patient, bracingelement 1613 holds communicator 1611 on body 102 by bracing a portion ofbody 102, such as the lower arm or wrist. In the illustrated embodiment,neurostimulation device 1604 is configured to be worn on the knee area,such as for stimulating the peroneal nerve at the acupuncture pointGB-34, and user communication device 1605 is configured to be worn on awrist, in the form of a wrist watch. In a specific embodiment, usercommunication device 1605 has the appearance of the neurostimulationdevice 1214 as illustrated in FIG. 12.

FIG. 17 is a block diagram illustrating an embodiment of portions of acircuit of system 1600. The circuit includes a communicator 1711 andexternal neurostimulator 1710 coupled to stimulation electrodes 214 andsensor 322. Communicator 1711 includes user interface 328 and acommunicator telemetry circuit 1794. External neurostimulator 1710includes stimulation output circuit 216, stimulation controller 318,memory circuit 220, stimulator telemetry circuit 324, and battery 326.Communicator telemetry circuit 1794 and stimulator telemetry circuit 324perform bi-directional communication between user interface 328 andstimulation controller 318 via telemetry link 1615. The circuit issubstantially similar to the circuit in FIG. 3 except that userinterface 328 is communicatively coupled to stimulation controller 318via telemetry link 1615.

FIGS. 18-21 illustrate additional examples of stimulation electrodescoupled to external neurostimulator 410, including its variousembodiments discussed in this document. In various embodiments,neurostimulation is delivered transcutaneously and/or percutaneouslyusing one or more pairs of stimulation electrodes such as thoseillustrated in FIGS. 5-11 and 18-21, as well as any other suitable pairsof surface and/or percutaneous electrodes.

FIG. 18 is an illustration of another embodiment of surface stimulationelectrodes coupled to external neurostimulator 410. Surface stimulationelectrode 656A is connected to external neurostimulator 410 using lead658A and is incorporated onto skin patch 659A, as discussed above withreference to FIG. 6. A surface stimulation electrode 1856B isincorporated onto the side of the chassis of external neurostimulator410 that is in contact of the surface of body 102 when being used. Oneexample of surface stimulation electrodes 1856B is surface stimulationelectrode 556A/B as discussed above. The electrode configurationillustrated in FIG. 18 differs from the electrode configurationillustrated in FIG. 6 in that one of the surface electrodes is connectedto external neurostimulator 410 using a lead, extending the range ofstimulation targets with external neurostimulator 410 placed on asurface location of body 102. This provides for transcutaneousneurostimulation when, for example, it is difficult to place externalneurostimulator 410 approximately over the stimulation target in body102.

FIG. 19 is an illustration of an embodiment of surface and percutaneousstimulation electrodes coupled to external neurostimulator 410.Percutaneous stimulation electrode 756A is a wire electrode including awire having a proximal end coupled to external neurostimulator 410 and adistal end configured to lodge in the specified stimulation site in body102, as discussed above with reference to FIG. 7. A surface stimulationelectrode 1956B is incorporated onto the side of the chassis of externalneurostimulator 410 that is in contact of the surface of body 102 whenbeing used. One example of surface stimulation electrodes 1956B issurface stimulation electrode 556A/B as discussed above. The electrodeconfiguration illustrated in FIG. 19 differs from the electrodeconfiguration illustrated in FIG. 7 in that one of the percutaneouselectrodes is replaced by a surface electrode. This reduces the degreethe invasiveness of the neurostimulation therapy.

FIG. 20 is an illustration of another embodiment of surface andpercutaneous stimulation electrodes coupled to external neurostimulator410. Percutaneous stimulation electrodes 856A is a wire electrodeincluding a wire having a proximal end coupled to externalneurostimulator 410 and a distal end configured to lodge in thespecified stimulation site in body 102, as discussed above withreference to FIG. 8. A surface stimulation electrode 2056B isincorporated onto the side of the chassis of external neurostimulator410 that is in contact of the surface of body 102 when being used. Oneexample of surface stimulation electrodes 2056B is surface stimulationelectrode 556A/B as discussed above. The electrode configurationillustrated in FIG. 20 differs from the electrode configurationillustrated in FIG. 8 in that one of the percutaneous electrodes isreplaced by a surface electrode. This reduces the degree theinvasiveness of the neurostimulation therapy.

FIG. 21 is an illustration of another embodiment of surface andpercutaneous stimulation electrodes coupled to external neurostimulator410. An implantable capsule 2162 includes a percutaneous stimulationelectrodes 2156A on one of its opposite ends. To deliver theneurostimulation, capsule 2162 is subcutaneously implanted, and a lead2158 provides a percutaneous connection between percutaneous stimulationelectrode 2156A and external neurostimulator 410. Implantable capsule2162 is substantially similar to implantable capsule 962 except thatonly one stimulation electrode is required to be incorporated onto thecapsule. A surface stimulation electrode 2156B is incorporated onto theside of the chassis of external neurostimulator 410 that is in contactof the surface of body 102 when being used. One example of surfacestimulation electrodes 2156B is surface stimulation electrode 556A/B asdiscussed above. The electrode configuration illustrated in FIG. 21differs from the electrode configuration illustrated in FIG. 9 in thatone of the stimulation electrodes is replaced by a surface electrode.This increases the distance between the pair of stimulation electrodeswhen needed.

FIG. 22 is a flow chart illustrating a method 2200 for modulating acardiovascular function using transcutaneous or percutaneousneurostimulation. In one embodiment, the method is performed by system100, 1400, or 1600.

An external neurostimulator is donned onto a patient at 2210, upondetermination that the patient is likely to benefit from atranscutaneous or percutaneous neurostimulation therapy. In oneembodiment, the patient has suffered an acute MI. The externalneurostimulator is held to a surface location of the patient's bodyusing a bracing element such as a belt, a strap, or a sleeve that bracesa portion of the body. In one embodiment, the transcutaneous orpercutaneous neurostimulation therapy is applied when the patient iswaiting to receive an implantable neurostimulator, when the use of animplantable neurostimulator is not justified, or when the use of anexternal neurostimulator is more beneficial to the patient when comparedto the use of an implantable neurostimulator for medical,administrative, and/or economical reasons.

Surface and/or percutaneous electrodes are placed at 2212. Surfaceelectrodes are used to deliver the transcutaneous neurostimulationtherapy. Percutaneous and/or surface electrodes are used to deliver thepercutaneous neurostimulation therapy. Examples of the surface and/orpercutaneous electrodes include those illustrated in FIGS. 5-11 and18-21, while all electrodes suitable for delivering transcutaneous orpercutaneous neurostimulation therapy may be used. Factors determiningthe choice between the transcutaneous neurostimulation therapy and thepercutaneous neurostimulation therapy include, for example, whether thepatient or a trained medical personnel administers the therapy delivery,location of the intended stimulation target, device availability, andduration and/or frequency of the use of the neurostimulation device.

The delivery of the neurostimulation is controlled by executing astimulation algorithm for modulating a cardiovascular function at 2214.In one embodiment, the execution of the stimulation algorithm isinitiated by a neurostimulation command received from a user or anotherdevice. In one embodiment, the stimulation algorithm provides for anopen-loop neurostimulation using predetermined stimulation parameters.In another embodiment, the stimulation algorithm provides for aclosed-loop neurostimulation using a feedback control signal to adjustthe stimulation parameters, including the starting and stopping of thedelivery of the neurostimulation. In one embodiment, the feedbackcontrol signal is indicative of whether the neurostimulation elicits theintended response from the target nerve. Examples of the feedbackcontrol signal include a cardiac signal, a blood pressure signal, aplethysmographic signal, and any other signal indicative of cardiacfunctions and/or hemodynamic performance of the patient.

The neurostimulation is delivered through the surface and/orpercutaneous electrodes at 2216. In one embodiment, the neurostimulationis a stand-alone therapy. In another embodiment, the neurostimulation issupplemental to a cardiac stimulation therapy such as a cardiacremodeling control therapy and/or other therapies such as drug andbiologic therapies.

It is to be understood that the above detailed description is intendedto be illustrative, and not restrictive. Other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. The scope of the invention should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1. A method for treating hypertension in a patient, comprising: holdingan external neurostimulator on a body surface of the patient using abracing element configured to brace a portion of the body; placingsurface stimulation electrodes on the body, including placing at leastone of the surface stimulation electrodes on an acupuncture point;executing a stimulation algorithm to transcutaneously deliverneurostimulation from the external neural stimulator to the acupuncturepoint to treat hypertension, wherein the stimulation algorithm includesparameters selected to modulate cardiovascular function to treathypertension; and timing the delivery of the neurostimulation accordingto a programmed schedule using a clock of the external neurostimulator,wherein placing the at least one of the surface stimulation electrodeson the acupuncture point comprises placing one or more of the surfacestimulation electrodes on the GB-34 on the Gall Bladder Meridian.
 2. Themethod of claim 1, wherein delivering the neurostimulation comprisesdelivering electrical neurostimulation pulses at a stimulation frequencybetween approximately 1 to 5 Hz.
 3. The method of claim 2, whereindelivering the neurostimulation comprises delivering the electricalneurostimulation pulses for approximately 0.5 to 24 hours each day. 4.The method of claim 1, further comprising sensing a feedback controlsignal, and wherein executing the stimulation algorithm totranscutaneously deliver neurostimulation comprises using the feedbackcontrol signal to control delivery of the neurostimulation.
 5. Themethod of claim 4, wherein sensing the feedback control signalcomprising sensing the feedback control signal using an implantablemedical device.
 6. A method for treating hypertension in a patient,comprising: holding an external neurostimulator on a body surface of thepatient using a bracing element configured to brace a portion of thebody; placing surface stimulation electrodes on the body, includingplacing at least one of the surface stimulation electrodes on anacupuncture point; executing a stimulation algorithm to transcutaneouslydeliver neurostimulation from the external neural stimulator to theacupuncture point to treat hypertension, wherein the stimulationalgorithm includes parameters selected to modulate cardiovascularfunction to treat hypertension; and timing the delivery of theneurostimulation according to a programmed schedule using a clock of theexternal neurostimulator, wherein placing the at least one of thesurface stimulation electrodes on the acupuncture point comprisesplacing one or more of the surface stimulation electrodes on the BL-14and BL-16 on the Bladder Meridian.
 7. The method of claim 6, whereindelivering the neurostimulation comprises delivering electricalneurostimulation pulses at a stimulation frequency between approximately1 to 5 Hz.
 8. The method of claim 7, wherein delivering theneurostimulation comprises delivering the electrical neurostimulationpulses for approximately 0.5 to 24 hours each day.
 9. The method ofclaim 6, further comprising sensing a feedback control signal, andwherein executing the stimulation algorithm to transcutaneously deliverneurostimulation comprises using the feedback control signal to controldelivery of the neurostimulation.
 10. The method of claim 9, whereinsensing the feedback control signal comprising sensing the feedbackcontrol signal using an implantable medical device.
 11. A method fortreating hypertension in a patient, comprising: holding an externalneurostimulator on a body surface of the patient using a bracing elementconfigured to brace a portion of the body; placing surface stimulationelectrodes on the body, including placing at least one of the surfacestimulation electrodes on an acupuncture point; executing a stimulationalgorithm to transcutaneously deliver neurostimulation from the externalneural stimulator to the acupuncture point to treat hypertension,wherein the stimulation algorithm includes parameters selected tomodulate cardiovascular function to treat hypertension; and timing thedelivery of the neurostimulation according to a programmed scheduleusing a clock of the external neurostimulator, wherein placing the atleast one of the surface stimulation electrodes on the acupuncture pointcomprises placing one or more of the surface stimulation electrodes onthe GV-11 on the Governing Vessel Meridian.
 12. The method of claim 11,wherein delivering the neurostimulation comprises delivering electricalneurostimulation pulses at a stimulation frequency between approximately1 to 5 Hz.
 13. The method of claim 12, wherein delivering theneurostimulation comprises delivering the electrical neurostimulationpulses for approximately 0.5 to 24 hours each day.
 14. The method ofclaim 11, further comprising sensing a feedback control signal, andwherein executing the stimulation algorithm to transcutaneously deliverneurostimulation comprises using the feedback control signal to controldelivery of the neurostimulation.
 15. The method of claim 14, whereinsensing the feedback control signal comprising sensing the feedbackcontrol signal using an implantable medical device.